Enhancing Telemedicine for T2D

Last updated: June 16, 2025
Sponsor: University of Pittsburgh
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Enhanced Telemedicine for Type 2 Diabetes

Usual Telemedicine Endocrinology Care for T2D

Clinical Study ID

NCT06740435
STUDY24060062
K23DK135794
  • Ages 18-80
  • All Genders

Study Summary

The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:

Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?

Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.

Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adults 18 years or older

  • Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medicalrecord or self-report

  • HbA1c greater than or equal to 8% based on most recent value at time of recruitment

  • Patients must own or have access to a smart phone, tablet, or home computer withdata or internet connection that allows access to video-based visits

  • Patient must use insulin

  • Patients must have >2 comorbid chronic health conditions

  • Be able to provide informed consent

  • Reside in Pennsylvania

Exclusion

Exclusion criteria:

  • Age over 80 based on date of birth in electronic medical record

  • Visit with an endocrinologist in the prior 1 years

  • Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical recordor self-report of associated condition

  • Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97,F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85

  • Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx,C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x,C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1,C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)

  • ESRD N18.6

  • Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below inmedical record or self-report of associated condition

  • Type 1 diabetes: E10.X

  • Gestational diabetes: O24.X, E08.X

  • Other diabetes: E09.X, E13.2

  • Pregnant or planning to become pregnant in next 6 months

  • Currently enrolled in another diabetes management intervention study

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Enhanced Telemedicine for Type 2 Diabetes
Phase:
Study Start date:
February 03, 2025
Estimated Completion Date:
July 30, 2026

Study Description

This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.

Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.

The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.

Connect with a study center

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

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